Blinded independent central review (BICR) is the process by which radiographic exams and selected clinical data performed as part of a clinical trial protocol are submitted to a central location for blinded review by independent physicians not involved in the treatment of the patients. Regulatory authorities recommend BICR for oncology registration studies when the primary study endpoint is based on tumor measurements, such as progression-free survival (PFS), time to progression (TTP), or objective response rate (ORR). Clinical trial sponsors have also used BICR in Phase I and II studies to assist in critical pathway decisions including in licensing of compounds.
There are different BICR review paradigms that are employed; however current United States Food and Drug Administration (USFDA) guidance recommends that multiple independent reviewers evaluate each subject. Consequently, BICR of industry-sponsored pivotal oncology studies generally includes the use of two independent radiologists evaluating each subject blinded to treatment arm, investigator assessments, and all clinical data.